MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES INZII RETRIEVAL SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CD001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is not being returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: lap chole.Event description: how was the device being used: no information was given- to be updated metal ring broke when deploying.No clinical impact to patient.16.02.2026 - additional information received from [name] (territory manager) via email: did patient injury or illness occur associated with the complaint event: no injury or illness how was the device being used/what action was being performed when the event occurred: lap chole procedure, inserting inzi cd001 through applied medical 5m trocars cffo3 describe the event, including relevant including any relevant information: when surgeon deploying the inzi cd001 through applied medical 5m trocars the metal arms dethatched from introducer.How did the user resolve the situation: they used another inzii cd001 bag with no issue what other instruments (if any) were used when the complaint event occurred: cff03 19.02.2026 in response to [applied medical team member] request for additional information: could you please confirm whether the customer is referring to the same component when they mention the ¿ring¿ and the ¿metal arms¿, or if they are describing two different parts of the device: yes, the customer was referring to the same component when they described metal ring they meant metal arms.Could you please confirm whether they intended to list the cffo3 trocar: no, the customer is not intending to cff03.Type of intervention: they used another inzii cd001 bag with no issue.Patient status: nill outcome to patent.No injury or illness.

• Brand Name: INZII RETRIEVAL SYSTEM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 24573138
• Report Number: 2027111-2026-00438
• Device Sequence Number: 18234176
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K060051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CD001
• Device Catalogue Number: 100864401
• Device Lot Number: 1560301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: APPLIED MEDICAL TROCAR.
• Patient Sex: Unknown